Non invasive ocular drug delivery trial promising for dry eye

Jun 10, 2009

In a dry eye Phase II clinical trial EyeGate Pharma reports that EGP-437, a corticosteroid solution administered by a non-invasive ocular drug delivery system, improved signs and symptoms in patients with dry eye syndrome (DES).

In a dry eye Phase II clinical trial EyeGate Pharma reports that EGP-437, a corticosteroid solution administered by a non-invasive ocular drug delivery system, improved signs and symptoms in patients with dry eye syndrome (DES).

For the trial, EyeGate worked with Ora, Inc. The single-center, randomized (105 patients), double-masked, placebo-controlled patient study evaluated the safety and efficacy of a corticosteroid solution (EGP-437) administered by the EyeGate II Delivery System (at two dose levels) twice over a three-week period. Ora's Controlled Adverse Environment (CAE) clinical research system, which simulates the acute environmental challenges regularly faced by DES patients, was used for this study.

In the top-level analysis, investigators observed that EGP-437 significantly (p

“This exploratory Phase II study demonstrated significant improvements in signs and symptoms of dry eye during and after CAE exposure following EGP-437 dosing. These effects were observed within hours of dosing, suggesting a rapid onset of action. In addition, EGP-437 significantly improved the post-CAE recovery for patients in the active treatment groups. The impact on signs and symptoms was also observed during the study's three-week environmental component, further supporting the potential benefits of EGP-437 for these patients,” commented George Ousler, director of Dry Eye Department at Ora.

According to Stephen From, president and CEO of EyeGate Pharma: “Ora's CAE clinical research system, which provides a unique ability to screen and qualify patients, played an integral role in minimizing the study's patient numbers while still delivering highly relevant biostatistics. We are excited about the prospect that EGP-437 may prove to be a useful therapy for the moderate to severe dry eye patients that are currently underserved by available treatments. This non-invasive drug delivery technology has the potential to help patients with a broad range of eye diseases, and we are encouraged by these results.”

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